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QAC — Screw Sleeve Bone Fixation Device Class II

FDA Device Classification

FDA product code QAC covers "Screw Sleeve Bone Fixation Device", a Class II medical device regulated under 21 CFR 888.3043. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
QAC
Device Class
Class II
Regulation Number
888.3043
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN180065woven orthopedic technologiesOGmend Implant SystemMay 1, 2020

FDA data resources